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Medical grade silicones are silicones tested for biocompatibility and are appropriate to be used for medical applications. [1] In the United States, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates devices implanted into the body. It does not regulate materials other than certain dental materials.
The fixed-dose procedure (FDP), proposed in 1992 by the British Toxicology Society, is a method to assess a substance's acute oral toxicity. [1] [2]In comparison to the older LD 50 test developed in 1927, this procedure produces similar results while using fewer animals and causing less pain and suffering. [3]
In its uncured state, silicone rubber is a highly adhesive gel or liquid. To convert it to a solid, it must be cured, vulcanized, or catalyzed.This is normally carried out in a two-stage process at the point of manufacture into the desired shape, and then in a prolonged post-cure process.
The exact mechanism of action of silicone gel sheeting has not been fully studied. Currently, many proposed mechanisms explain the efficacy of such treatment, including the occlusion and hydration effect, increased body surface temperature, polarized electric charge, immunological effects, etc. [9] The occlusion and hydration effect is the most studied mechanism of action.
In toxicology, the median lethal dose, LD 50 (abbreviation for "lethal dose, 50%"), LC 50 (lethal concentration, 50%) or LCt 50 is a toxic unit that measures the lethal dose of a given substance. [1] The value of LD 50 for a substance is the dose required to kill half the members of a tested population after a specified test duration.
The Common Terminology Criteria for Adverse Events (CTCAE), [1] formerly called the Common Toxicity Criteria (CTC or NCI-CTC), are a set of criteria for the standardized classification of adverse events of drugs and treatment used in cancer therapy. The CTCAE system is a product of the US National Cancer Institute (NCI).
Injection molding of liquid silicone rubber (LSR) is a process to produce pliable, durable parts in high volume.. Liquid silicone rubber is a high purity platinum cured silicone with low compression set, good stability and ability to resist extreme temperatures of heat and cold ideally suitable for production of parts, where high quality is required.
Animal models are used to learn more about a disease, its diagnosis and its treatment, with animal models predicting human toxicity in up to 71% of cases. [1] The human equivalent dose (HED) or human equivalent concentration (HEC) is the quantity of a chemical that, when administered to humans, produces an effect equal to that produced in test animals by a smaller dose. [2]